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Accreditation Formal certification of quality by an independent authorized body. What is “quality”? Doing the right thing at the right time for the right reasons and doing it right. What is right? Need for standards, guidelines & warranties

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Laboratory Accreditation Procedure by which an authorized body (e.g. NABL, CAP ) gives formal recognition that a laboratory or person (signatory) is competent to carry out specified tasks (scope). Third Party audit against defined criteria.

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Laboratory Accreditation Certifies validity of technical procedures. Certifies competence of the laboratory to carry out the scope. Certifies compliance with the stated quality system. Endorses the quality management system of the audited lab.

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Laboratory Accreditation Accreditation is not licensing. Licensing is mandatory. Licensing requires compliance with minimal criteria. Licensing does not involve a compliance (implementation) audit. Licensing does not assure technical quality. Licensing in some instances may require accreditation.

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Why Laboratory Accreditation ? Growing public interest in the quality of health care. Demand for accountability because of high cost. Increasing public expectations from all health care providers. Privatization of health insurance and the advent of managed health care. Business imperatives: CRO, clinical trial patients.

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ISO 15189 2007 International Standard Five clauses 1.Scope 2.Normative references 3.Terms & definitions 4.Management requirements 5.Technical requirements Three appendices one of which is on ethics

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NABL- 112 Specific Guidelines for Clinical laboratories Guidelines that must be complied with over and above ISO -15189. Local Indian and State Regulations eg.  Notifiable diseases  NACO guidelines  Bio waste management Classification of Labs Retention times for samples Qualifications for authorised signatories

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Laboratory Accreditation The Indian Scene- NABL Accreditation Application with quality manual Pre-assessment (Lead assessor * & 1 technical assessor * ) Final assessment ( LA + TA for each area of assessment) Re-assessment after 2 years with a desk-top audit in the intervening year. * All assessors are trained

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Accreditation Committee NABL Certificate for the certified scope alone. Unauthorised or wrongful use of the certificate can lead to suspension of accreditation. Laboratory Accreditation The Indian Scene- NABL Accreditation

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NABL Assessment Not an examination. Assessors are not out to find inconsequential faults. They are looking for  Knowledge of quality systems among concerned staff.  Systematic implementation of QS.  Problems that will seriously affect the quality of a test result.  Willingness of the lab management to improve. Mutually beneficial learning experience for the lab and assessors. Observations & suggestions.. Confidentiality is key. Success requires informed and balanced assessors and assessees with a commitment to quality.

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Laboratory Accreditation Should accreditation become mandatory? Will accreditation become mandatory?

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Future of Private Lab Medicine Decline of small neighbourhood labs run by MDs in urban areas. Growth of large laboratory conglomerates with centralized testing. Increased testing of well individuals to offset quality costs and competition by economies of scale. Growth of single specialty labs e.g. hematology, microbiology, histopathology labs. Accreditation by peer pressure. Mandatory accreditation and/ or licensing.

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Future of Private Lab Medicine: Problems Issues of analyte stability on transport (preanalytic issues; issues pertaining to collection centres) Quality issues for point of care and emergency testing Logistics of Accreditation of Labs & PT providers. Mushrooming of licensed but unaccredited labs. Price wars Need for a wise clinical laboratory regulatory act that recognises that non-medical personnel can and do render quality services, both in underserved areas of this country and in high end labs.

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Laboratory Accreditation The Future Laboratory Accreditation is here to stay. The future of laboratory medicine will be changed forever.

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